Safety Board Recommends BioCardia's Heart Failure Cell Therapy To Continue Unchanged

The independent Data Safety Monitoring Board (DSMB) has completed its prespecified data review for BioCardia Inc's BCDA ongoing Phase 3 CardiAMP Cell Therapy Heart Failure Trial.

• The DSMB based its review on all available data for the 108 patients enrolled with an additional six crossover patient procedures in the trial to date. 
• The monitoring board's assessment indicated no significant safety concerns and recommended that the study continue as designed.  
• The ongoing CardiAMP Heart Failure Trial is expected to enroll 260 patients. 
• CardiAMP Cell Therapy System received FDA Breakthrough Device status for heart failure earlier this month.
• The trial's primary endpoint is an outcomes composite score based on a hierarchical analysis of the three-tiered Finkelstein-Schoenfeld (FS).
• The FS procedure is a ranked analysis that compares the occurrence of cardiovascular and other health-related events, along with functional capacity measures, through one year in patients.
• Price Action: BCDA shares are down 4.10% at $2.34 during the market session on the last check Monday.